Title 21: Food and Drugs
PART 529—CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS
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§ 529.1030 Formalin.
(a) Specifications. Formalin is an aqueous solution containing approximately 37 percent by weight of formaldehyde gas, U.S.P.
(b) Sponsors. See sponsors in §510.600(c) of this chapter for uses as in paragraph (d) of this section.
(1) Nos. 049968 and 050378 for use as in paragraphs (d)(1)(iii), (d)(1)(iv), (d)(1)(v), (d)(2)(iii), (d)(2)(iv), (d)(2)(v), and (d)(3).
(2) No. 051212 for use as in paragraphs (d)(1)(i), (d)(1)(ii), (d)(2)(i), (d)(2)(ii), and (d)(3).
(c) [Reserved]
(d) Conditions of use. It is added to environmental water as follows:
(1) Indications for use. (i) Select finfish. For control of external protozoa Ichthyophthirius spp., Chilodonella spp., Costia spp., Scyphidia spp., Epistylis spp., and Trichodina spp., and monogenetic trematodes Cleidodiscus spp., Gyrodactylus spp., and Dactylogyrus spp., on salmon, trout, catfish, largemouth bass, and bluegill.
(ii) Select finfish eggs. For control of fungi of the family Saprolegniaceae on salmon, trout, and esocid eggs.
(iii) Penaeid shrimp. For control of external protozoan parasites Bodo spp., Epistylis spp., and Zoothamnium spp.
(iv) All finfish. For control of external protozoa Ichthyophthirius spp., Chilodonella spp., Costia spp., Scyphidia spp., Epistylis spp., and Trichodina spp., and monogenetic trematodes Cleidodiscus spp., Gyrodactylus spp., and Dactylogyrus spp.
(v) All finfish eggs: For control of fungi of the family Saprolegniaceae.
(2) Amount. The drug concentrations required are as follows:
(i) For control of external parasites on select finfish:
------------------------------------------------------------------------ Concentration of formalin (microliters per liter) ------------------------------------- Fish Tanks and raceways (for up to 1 hour Earthen ponds daily) (indefinitely)------------------------------------------------------------------------Salmon and trout: Above 50 °F............... Up to 170........... 15-25 Below 50 °F............... Up to 250........... 15-25 Catfish, largemouth bass, and Up to 250........... \1\ 15-25 bluegill.------------------------------------------------------------------------\1\ Use the lower concentrations when pond is heavily loaded with fish or phytoplankton.
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(ii) For control of fungi of the Saprolegniaceae on salmon, trout, and esocid eggs: Apply in constant flow water supply of incubating facilities for 15 minutes. Concentration of formalin used is 1,000 to 2,000 microliters per liter.
(iii) For control of external protozoan parasites on shrimp:
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------------------------------------------------------------------------ Concentration of formalin (microliters per liter) --------------------------------------- Shrimp Tanks and raceways (up to 4 hours Earthen ponds daily) (single treatment)------------------------------------------------------------------------Penaeid Shrimp.................. 50 to 100 \1\..... 25 \2\------------------------------------------------------------------------\1\ Treat for up to 4 hours daily. Treatment may be repeated daily until parasite control is achieved. Use the lower concentration when the tanks and raceways are heavily loaded.\2\ Single treatment. Treatment may be repeated in 5 to 10 days if needed.
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(iv) For control of external parasites on all finfish:
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------------------------------------------------------------------------ Administer in tanks and raceways for up to 1 Administer in earthen Aquatic species hour (microliter/liter ponds indefinitely or part per million (µL/L or ppm) (µL/L or ppm))------------------------------------------------------------------------Salmon and trout: Above 50 °F Up to 170 15 to 25 \1,2\Below 50 °F Up to 250 15 to 25 \1,2\All other finfish Up to 250 15 to 25 \1,2\------------------------------------------------------------------------\1\ Use the lower concentration when ponds, tanks, or raceways are heavily loaded with phytoplankton or fish to avoid oxygen depletion due to the biological oxygen demand by decay of dead phytoplankton. Alternatively, a higher concentration may be used if dissolved oxygen is strictly monitored.\2\ Although the indicated concentrations are considered safe for cold and warm water finfish, a small number of each lot or pond to be treated should always be used to check for any unusual sensitivity to formalin before proceeding.
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(v) For control of fungi of the family Saprolegniaceae on all finfish eggs: Eggs of all finfish except Acipenseriformes, 1,000 to 2,000 µL/L (ppm) for 15 minutes; eggs of Acipenseriformes, up to 1,500 µL/L (ppm) for 15 minutes.
(3) Limitations. Fish tanks and raceways may be treated daily until parasite control is achieved. Pond treatment may be repeated in 5 to 10 days if needed. However, pond treatments for Ichthyophthirius should be made at 2-day intervals until control is achieved. Egg tanks may be treated as often as necessary to prevent growth of fungi. Do not use formalin which has been subjected to temperatures below 40 °F, or allowed to freeze. Do not treat ponds containing striped bass. Treatments in tanks should never exceed 1 hour even if fish show no signs of stress. Do not apply formalin to ponds with water warmer than 27 °C (80 °F), when a heavy bloom of phytoplankton is present, or when the concentration of dissolved oxygen is less than 5 milligrams per liter.
[51 FR 11441, Apr. 3, 1986, as amended at 58 FR 59169, Nov. 8, 1993; 59 FR 60076, Nov. 22, 1994; 63 FR 38304, July 16, 1998; 68 FR 5563; Feb. 4, 2003]
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